K-Klosure 2 Inch LENGTH/4 Inch LENGTH/8 Inch LENGTH/12 Inch Length
FDA 510(k) K970441 · Medi-Flex Hospital Products, Inc.
510(k) numberK970441
Submission
- Device name
- K-Klosure 2 Inch LENGTH/4 Inch LENGTH/8 Inch LENGTH/12 Inch Length
- Applicant
- Medi-Flex Hospital Products, Inc.
Overland Park, KS, US - Received
- February 5, 1997
- Decision date
- May 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FPX – Strip, Adhesive, Closure, Skin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5240
- Specialty
- General Hospital
Other 510(k)s with product code FPX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952947 | Delpore Skin ClosureFPX · Traditional | Bitco Intl. | 07/24/1995SE |
| K952702 | Derma SealFPX · Traditional | Ttl Medical | 06/28/1995SE |
| K946321 | Biostrip Sterile Wound Closure StripFPX · Traditional | Cornelia Damsky, Inc. | 01/12/1995SE |
| K931005 | Dukal Skin Closure StripFPX · Traditional | Dukal Corp. | 07/14/1993SE |
| K921775 | Spyroflex Wound ClosuresFPX · Traditional | Polymint Industrial Co. , Ltd. | 05/19/1992SE |
| K894802 | Awc Butterfly Wound ClosuresFPX · Traditional | American White Cross, Inc. | 01/31/1990SE |
| K894205 | Tecnol Silk StripFPX · Traditional | Tecnol New Jersey Wound Care, Inc. | 07/25/1989SE |
| K874813 | Omed Wound Closure StripsFPX · Traditional | Oxboro Medical Intl., Inc. | 01/29/1988SE |
| K840945 | Skin ClosureFPX · Traditional | Gainor Medical | 10/31/1984SE |
| K842621 | Suture StripFPX · Traditional | Genetic Laboratories, Inc. | 10/25/1984SE |
More from Genetic Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K962740 | Dermistick Sepp APPLICATOR(200 CT)/(40 CT) 260640/260641KMF · Traditional | 09/06/1996SE |
| K952201 | Port-A-Cath Access KitFMF · Traditional | 10/04/1995SE |
| K952416 | Tracheostomy Care KitBTO · Traditional | 08/09/1995SESK |
| K952256 | Picc Line KitFOZ · Traditional | 07/31/1995SE |
| K952007 | Adherol Sepp ApplicatorFRO · Traditional | 06/08/1995SE |
| K934790 | Sepp Adhesive RemoverKOX · Traditional | 03/11/1994SE |
| K923516 | Compound Benzoin Tincture Usp SeppKMF · Traditional | 01/25/1994SE |
| K920399 | Compound Benzoin Tincture Usp FreppKMF · Traditional | 01/25/1994SE |
| K930196 | Cepti-Seal I.V. Prep KitLRS · Traditional | 07/02/1993SEKD |
| K921347 | Cepti-Seal Dressing Change Kit for Venous CatheterMCY · Traditional | 01/08/1993SEKD |
Questions and answers
When was K-Klosure 2 Inch LENGTH/4 Inch LENGTH/8 Inch LENGTH/12 Inch Length cleared by the FDA?
K-Klosure 2 Inch LENGTH/4 Inch LENGTH/8 Inch LENGTH/12 Inch Length (K970441) received a 510(k) decision of Substantially Equivalent on May 9, 1997, 93 days after the submission was received.
What is the product code of K970441?
The FDA product code is FPX – Strip, Adhesive, Closure, Skin, a Class I (low risk) device regulated under 21 CFR 880.5240.